14 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

10M - The Braun Corp.10311-WI

FDA UDI
Certified Safety Manufacturing, Inc.·00766588095387·10M - The Braun Corp.10311-WI

NorthStar

FDA UDI
Seaspine Orthopedics Corporation·10889981197483·Smooth Shank Poly. Screw, 3.5mm x 38mm

TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER

FDA 510(k)
FDA Class 2 ·General Hospital

TDP CQ-27 HEAT LAMP

FDA 510(k)
FDA Class 2 ·Physical Medicine

Gibralt

FDA UDI
Choice Spine, LP·10885862247575·

Gibralt®

FDA UDI
INNO Holdings, Inc.·M711050002035380·Posterior Cervical Screw Assembly, 3.5mm X 38mm...

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 27, 2014

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 3, 2013

VASSALLO GT

FDA Adverse Event
Injury ·FILMECC CO., LTD.·Product code DQX·October 3, 2024

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

EMBLEM MRI S-ICD Model A219

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012